InfluenzaPhase 1/2PSC26NCT02464163
Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older
A Phase 1/2 study testing Panblok and rHA adjuvant in people with Influenza, run by Protein Sciences Corporation at 9 sites in United States.
Trial summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Panblok and rHA adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2015to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, regardless of gender, aged 18 years and above
- Able to give written informed consent to participate.
- Body temperature <100.0ºF.
- The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history.
- Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
- Women are considered not of child-bearing potential if they are:
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- Surgically sterile
- Menopausal, defined as no natural menses for ≥12 months
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.
Who cannot join
- Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.
- Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.
- Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.
- Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
- Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- Persons with a history of documented autoimmune disease.
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- Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.
- Persons who have had a prior serious reaction to any influenza vaccine.
- Persons with a known history of Guillain-Barré Syndrome (GBS).
- Persons with a history of anaphylactic-type reaction to injected vaccines.
- Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.
- Persons who received a seasonal influenza vaccine < 6 months prior to enrollment (may delay enrollment).
- Persons who received any licensed inactivated or recombinant (non-live) vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment (may delay enrollment) (See separate exclusion criteria #1 and #12 for seasonal and H5N1 influenza vaccines.)
- Persons who have had an acute illness or fever (>38º C or >100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).
- Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
- Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Benchmark Reseach
Austin, Texas, 78705
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Avail Clinical Research
DeLand, Florida, 32720
Regional Clinical Research, Inc.
Endwell, New York, 13760
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135
Coastal Clinical Research
Mobile, Alabama, 36608
Meridian Clinical Research
Omaha, Nebraska, 68164
Jean Brown Research
Salt Lake City, Utah, 84124
Meridian Clinical Research
Savannah, Georgia, 31406
About this study
Official title: Phase 1/2 Adaptive Design Trial to Evaluate the Immunogenicity and Safety of Panblok (H7 rHA) at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With Unadjuvanted H7 rHA in Healthy Adults Aged 18 and Older
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Read the detailed description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
- Conditions
- Influenza
- Being tested
- Panblok, rHA adjuvant
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanblokBiological
Also called recombinant hemagglutinin, rHA
Intramuscular injection
rHA adjuvantBiological
Also called SE
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Panblok 30µg in 2% SE | Experimental | 30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: Panblok; Biological: rHA adjuvant |
| Panblok 15µg in 2% SE | Experimental | 15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: Panblok; Biological: rHA adjuvant |
| Panblok 7.5µg in 2% SE | Experimental | 7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: Panblok; Biological: rHA adjuvant |
| Panblok 30µg (No Adjuvant) | Experimental | 30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: Panblok |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.
Measured: 42 Days
Secondary outcomes (3)
Reactogenicity Immediately After Each Injection, Extending to Day 7
Solicited events of local and systemic reactogenicity Days 0-7
Measured: 7 Days
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Measured: 13 months
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Unsolicited adverse events (UAEs) Days 0-42.
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John J Treanor, MD, Principal investigator, University of Rochester Center for Vaccine Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464163
- Sponsor's protocol ID
- PSC26
- Acronym
- PSC26
- Status last verified
- Sep 2017
- First submitted
- 1 Jun 2015
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Adaptive Design Trial to Evaluate the Immunogenicity and Safety of Panblok (H7 rHA) at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With Unadjuvanted H7 rHA in Healthy Adults Aged 18 and Older
- ClinicalTrials.gov ID
- NCT02464163
- Acronym / sponsor ID
- PSC26 / PSC26
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 26 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Detailed description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panblok 30µg in 2% SE | Experimental | Biological: Panblok, Biological: rHA adjuvant30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| Panblok 15µg in 2% SE | Experimental | Biological: Panblok, Biological: rHA adjuvant15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| Panblok 7.5µg in 2% SE | Experimental | Biological: Panblok, Biological: rHA adjuvant7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| Panblok 30µg (No Adjuvant) | Experimental | Biological: Panblok30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults, regardless of gender, aged 18 years and above
- Able to give written informed consent to participate.
- Body temperature <100.0ºF.
- The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history.
- Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
Key exclusion criteria (16 listed)
- Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.
- Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.
- Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.
- Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
- Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanblokAlso: recombinant hemagglutinin, rHAIntramuscular injection | Biological | Panblok 15µg in 2% SE, Panblok 30µg (No Adjuvant), Panblok 30µg in 2% SE, Panblok 7.5µg in 2% SE |
| rHA adjuvantAlso: SEIntramuscular injection | Biological | Panblok 15µg in 2% SE, Panblok 30µg in 2% SE, Panblok 7.5µg in 2% SE |
Primary outcome
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
Time frame: 42 Days
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.
3 secondary outcomes
Reactogenicity Immediately After Each Injection, Extending to Day 7
Time frame: 7 Days
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time frame: 13 months
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Time frame: 42 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Treanor, MD principal investigator
University of Rochester Center for Vaccine Studies
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panblok and rHA adjuvant in people with Influenza, run by Protein Sciences Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. (time frame: 42 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.